Sunesis Pharmaceuticals Inc. has filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for SNS-314, an internally-developed anticancer product candidate. SNS-314 is a targeted small molecule that selectively inhibits the Aurora kinases.

Aurora kinases are key enzymes involved in cancer cell growth and division, and have a central role in the abnormal growth and proliferation of tumour cells.

"We are pleased to be advancing our third oncology programme into the clinic with the filing of this IND for our Aurora kinase inhibitor, SNS-314. We anticipate treating patients with advanced solid tumours in the second quarter," said Daniel Swisher, Sunesis' CEO and president. "SNS-314 was discovered using Sunesis' integrated discovery science platform, resulting in what we believe is a potential 'best-in-class' compound."

"We look forward to initiating clinical studies of SNS-314, which has demonstrated strong anti-proliferative activity across a number of different tumour models," said Daniel Adelman, MD, senior vice president, Research and Development at Sunesis. "In particular, we are pleased to see that SNS-314 behaves selectively and specifically against Aurora kinases. With SNS-314, we have observed robust, dose-dependent activity under multiple dosing schedules, which should provide greater dosing flexibility in the clinic than competitor candidates. In our first phase 1 study, we plan to dose SNS-314 intravenously on a weekly basis."

Discovered by Sunesis using Tethering, the company's fragment-based discovery engine, SNS-314 is a potent and selective inhibitor of Aurora kinases A, B, and C SNS-314 targets the uncontrolled cellular proliferation associated with cancer by halting cell division at the mitotic phase of the cell cycle. In nonclinical studies, SNS-314 has demonstrated robust anti- tumour activity on an intermittent dosing schedule across diverse tumour models. Based on the broad nonclinical activity observed in xenograft models, Sunesis plans to initially evaluate SNS-314 as a single agent in patients with advanced solid tumour malignancies.

Sunesis has built a rich portfolio of product candidates in oncology focused on novel pathways and targets, including inhibition of the cell-cycle and survival signaling. Sunesis is currently conducting phase 2 and phase 1 clinical trials in lung cancer, ovarian cancer and acute myeloid leukaemia for its lead compound, SNS-595.